Certified Medical Translations
Our experts in certified medical translations can help navigate global health regulations and deliver high quality multilingual content to support patient centric communications.
Certified medical translations play a vital role in life sciences localization, giving purchasers the assurance that their content is tailored to specification for use in global markets. As one of the most highly regulated industries worldwide, characterized by highly specific policies and mandates from governments and regulatory bodies, the life sciences, and specifically certified medical documents, present some of the strictest requirements for document submissions.
With a global network of 10,000+ linguists and subject matter experts in areas including patient recruitment translations, CTD and eCTD translations, and medical research document translations, CSOFT Health Sciences offers a full range of localization solutions for certified medical translations, including:
Certified Clinical Trial Translations
Clinical trials account for an enormous portion of the investment required to bring drug therapies, medical devices, and treatments to market in any country. For pharmaceutical companies expanding in overseas markets, clinical trial translation is crucial to meet local regulatory requirements. However, inaccurate translation risks regulatory viability in the target market, as well as potentially endangers patient safety and drug efficacy, making precise, quality translation an essential priority.
CSOFT Health Sciences’ global network of in-country linguists and clinical trial translation specialists enables clear, precise, consistent certified translations for all document types and phases of the clinical process, including remote clinical trials. From informed consent forms for participants to investigator’s brochures, our subject matter experts ensure the highest possible quality with rapid turnaround through the help of world-class translation tools and processes.
Learn more about certified clinical trial translations.
Certified Regulatory Submission Translations
Across life science industries, meeting regulatory compliance standards is an essential step in gaining market access, making regulatory translation a hugely important investment. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and China’s National Medical Products Administration (NMPA) all require data and documentation to ensure the efficacy and safety of products entering the local market. To gain regulatory compliance, accurate translation of regulatory documentation and data is critical for life science companies to be successful when expanding overseas. CSOFT Health Sciences offers a wide range of professional, certified regulatory document translations to meet strict global regulatory standards.
Learn more about certified regulatory submission translations.
Certified Technical Translations
Medical technical documentation and other forms of technical content is often subject to high levels of scrutiny to ensure the accuracy and validity of its subject matter. Across industries, certification may be necessary in some cases to satisfy official entities or other stakeholders in the quality and accuracy of technical translations.
For companies with stringent requirements for technical translation, CSOFT Health Sciences’ certified translators and subject matter experts can work to ensure the total accuracy and consistency of their technical content, delivering multilingual documents with the backing of a credible certification.
Learn more about our certified technical translation solutions.
Good Documentation Practices (GDP) Translations
Good Documentation Practices (GDP), also referred to as GDocP, describes a set of standards that are designed for the pharmaceutical and medical device industries and required by most regulatory bodies including the FDA, EMA, NMPA, TGA, and more. These procedures are typically carried out electronically, and mandates for life science companies to keep a variety of documented records throughout the product’s lifecycle. High quality certified medical translations of these documents is essential for international regulatory compliance.
Learn more about our Good Documentation Practices (GDP) Translations.
High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015,ISO 9001:2015, and ISO 13485:2016 certified quality management system.
Learn more about our quality assurance process.
CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are certified with ISO 13485:2016, ISO 9001:2015, and ISO 17100:2015, and leverage best practices from ISO 27001.
Learn more about how CSOFT protects companies’ data.